Development and validation of colorectal cancer and colonoscopy screening health beliefs scale for first-degree relatives of people with colorectal cancer (CCHBS-FDR) in China.

Introduction
First-degree relatives (FDRs), including parents, offspring, and siblings who share approximately 50% of their genetic information with an affected individual, face significantly elevated risks of developing colorectal cancer (CRC).1 In particular, FDRs are estimated to have a 2- to 4-fold increased risk of developing CRC compared to the general population.2 Given the increased risk, colonoscopy is considered the gold standard screening method for these individuals, as it effectively detects and removes both precancerous polyps and early cancerous lesions.3 Multiple studies have demonstrated the effectiveness of regular colonoscopy screening in reducing CRC risk,4, 5, 6 with a recent randomized controlled trial further confirming that regular colonoscopy could reduce the risk of developing CRC by 18% over a 10-year period.7 Consistent with ongoing evidence, current authorized guidelines recommend that FDRs begin colonoscopy screening at age 40 or 10 years before the age of diagnosis of the youngest affected relative. Nevertheless, their participation in colonoscopy screening remains suboptimal. A systematic review study showed that globally, the combined rate of colonoscopy screening uptake among FDRs is only 40%.8 The situation is even more concerning in China, where fewer than 20% of FDRs undergo colonoscopy screening.9,10
Despite the established benefits of colonoscopy screening, the low uptake among FDRs underscores the need to understand the underlying factors that influence their screening behaviors. Health belief model (HBM) provides a valuable framework for understanding disease prevention and screening-related behaviors.11 Based on this theoretical foundation, tailored communication interventions have emerged as a promising approach, with numerous studies demonstrating their effectiveness in promoting screening behaviors.12, 13, 14, 15, 16, 17, 18, 19 These interventions typically provide risk-appropriate information based on individuals' perceived susceptibility, severity and benefits levels, along with targeted strategies to overcome specific screening barriers. A valid and reliable instrument enables the identification of individuals who perceive lower risk, lower severity, or fewer benefits of screening. By capturing these perceptions, the instrument enables the tailoring of personalized intervention content based on specific items to address particular misconceptions or motivational gaps. Additionally, individuals with high scores on perceived barriers can be targeted with intervention components designed to address their specific concerns, such as logistical challenges, emotional distress, or insufficient knowledge.20 The effectiveness of such interventions heavily relies on accurate assessment tools that can precisely measure perceived susceptibility, severity and benefits levels, while also capturing culture-specific barriers that may arise from different cultural perspectives on cancer risk and prevention. Therefore, a valid and reliable instrument to measure these health belief concepts is essential for implementing successful screening promotion strategies.
Our team previously translated, adapted, and validated the Colorectal Cancer Perceptions Scale (CRCPS), resulting in the 38-item Simplified Chinese version of the Revised Colorectal Cancer Perception and Screening (RCRCPS) instrument.21 While the RCRCPS instrument demonstrated acceptable reliability and validity, providing an initial Chinese instrument for investigating health beliefs related to CRC and colonoscopy screening,9 several limitations emerged during its practical implementation. One significant limitation of the original RCRCPS was identified in the risk perception subscale. The original RCRCPS contained several items with highly similar meanings in the Chinese context, making it challenging for respondents to differentiate between them (Appendix A). Furthermore, the temporal expressions “in the next few years,” “sometime,” and “in the near future” in the original items are inherently vague, lacking precise timeframes, which may lead to respondent uncertainty. These ambiguities imposed a significant cognitive burden and, in some cases, questionnaire abandonment during the risk assessment phase, limiting its applicability in real-world settings.
In addition to this issue, items addressing career and marital changes in the severity subscale, these consistently received low scores in previous surveys,9 indicating that such factors are not commonly perceived as severe consequences by the Chinese population. Conversely, concerns more directly relevant to FDRs—such as their ability to provide care for patients or maintain family stability—are often prioritized but were insufficiently represented in the original scale. Moreover, the subscale did not fully encompass the physical and psychological impacts of CRC, which are fundamental to an accurate assessment of perceived severity. These gaps suggest that the need for a re-development of the severity subscale to better align with culturally relevant perceptions and to enhance its ability to predict screening behaviors.
Finally, the barrier and benefits perception subscale lacked items addressing culturally specific obstacles to screening behaviors. For instance, many Chinese FDRs indicate apprehension that engaging in colonoscopy screening and managing potential adverse outcomes could interfere with their primary caregiving duties for CRC patients.22, 23, 24 Additionally, barriers such as discomfort during the bowel preparation process, concerns about the adverse effects of anesthesia, and a lack of knowledge about colonoscopy are considered significant barriers to colonoscopy screening behavior in Chinese population,25 were not involved. This omission reduced the cultural relevance of the instrument and limited its capacity to inform culturally sensitive interventions.
In response to these limitations, it has become essential to redesign the instrument to enhance its validity, cultural specificity, and practical applicability. The present study aims to develop the Colorectal Cancer and Colonoscopy Screening Health Beliefs Scale for First-Degree Relatives (CCHBS-FDR), which will offer a more comprehensive and accurate measure of health beliefs related to CRC and colonoscopy screening among FDRs in China. The development of CCHBS-FDR will be informed by items from the RCRCPS,21 influencing factors identified in the systematic review,22 and qualitative interviews conducted with 42 CRC patients and their relatives.

Methods

Study design
To ensure methodological rigor in the instrument updating process, the development of CCHBS-FDR instrument in this study was conducted following DeVellis's scale development methodology.26 This study was conducted in two phases: Phase I, the scale development phase, guided by the HBM, we combined insights from the RCRCPS,21 a systematic review,22 and a qualitative interview (n ​= ​42) that previously conducted by research team on the factors influencing colonoscopy screening behavior among the FDRs of CRC patients, to develop the CCHBS-FDR, which better aligns with the perceptions and cultural context of FDRs in China. Phase II, the scale validation phase, involved a cross-sectional survey to evaluate the scale's psychometric properties, including validity and reliability. Adaptation and psychometric properties designed for convenience sampling were used in this study and verified in the FDRs of CRC patients in China. The development and validation process was shown in Fig. 1.

Phase I: the scale development phase

Construct clarification and item generation
A clear definition of the evaluated concept and measurement structure is essential for a scale.27 The framework of the scale was based on the key components of the HBM. The items derived from the RCRCPS,21 the only existing instrument assessing health beliefs among FDRs of CRC patients, were served in the item pool. To create a comprehensive item pool, we conducted a mixed-method review of studies related to factors influencing colonoscopy behaviors among FDRs of CRC patients, with specific findings reported in our team previous research.22 Then, to gain insight into the culture-specific perceptions of Chinese FDRs regarding CRC and colonoscopy, semi-structured interviews were conducted with FDRs and CRC patients (n ​= ​42).

Item design and measurement method selection
Based on the item pool, scale development should emphasize clarity and simplicity in item compilation while avoiding redundancy. The language used should be familiar to the respondents (Simplified Chinese), maintain readability, and avoid ambiguity, vagueness, or professional terms. The statement and response formats of the scale items were determined through a review of previous literature and team discussions.

Expert committee review
Two rounds of expert consultation were conducted using the Delphi method. The expert panel (n ​= ​10) comprised 2 physicians specializing in cancer screening, 2 chief nurses engaged in CRC care and colonoscopy screening, and 6 researchers in cancer screening and disease prevention. Ten experts were invited to evaluate the degree of relevance and importance of each item, using a four-point Likert scale ranging from 1 (not relevant) to 4 (very relevant). Following the initial consultation, we summarized and statistically analyzed the experts' responses. The scale was then modified based on the experts' suggestions and in-depth discussions with the scale developers. Subsequently, the experts re-evaluated the modified scale. Finally, to assess content validity, we calculated the content validity index at the item level (I-CVI) and the content validity index at the scale level (S-CVI). The I-CVI was determined by the percentage of experts who rated an item as 3 or 4. The S-CVI was computed as the percentage of items that achieved a rating of 3 or 4 by all the experts. I-CVI > 0.78 and S-CVI > 0.9 indicates good content validity.28 Items rated by the expert panel as not relevant or unable to assess relevance were revised.

Pilot testing
After the expert content validity verification, to assess the comprehensibility and feasibility of the CCHBS-FDR among the target population, 10 Chinese FDRs of CRC patients were invited for pilot test. Age is an established risk factor for CRC, with incidence rates increasing progressively with advancing age.29 The American College of Gastroenterology (ACG) recommends in its latest guidelines that individuals with a positive family history should initiate CRC screening with a colonoscopy at age 40 or 10 years before the youngest affected relative, for individuals with CRC or advanced polyp in 1 FDR at age 60 years or CRC or advanced polyp in 2 FDR at any age.3 The National Comprehensive Cancer Network (NCCN) also states that FDRs of diagnosed CRC patients should begin risk assessment and screening at the age of 40.30 In China, the incidence of CRC exhibits an upward trend from the age of 40 years.31,32 The latest national guidelines released in 2020 recommend initiating CRC screening at age 40 for high-risk populations or 10 years earlier than the youngest diagnosed FDRs, which effectively mitigates CRC risk.33 For individuals over 75 years, the guidelines emphasize a personalized screening plan rather than routine screening, given considerations of life expectancy and elevated risks of screening-related complications in elderly populations. Therefore, based on the recommendations of authoritative guidelines, the age of FDRs recruited in this study was accordingly defined as 40–75 years old or 10 years earlier than the youngest diagnosed CRC patient in their family. The inclusion criteria of FDRs were as follows: (1) FDRs (parent, sibling, or children) of patients with CRC; and (2) age between 40 and 75, or within the first 10 years of the age of diagnosis of FDRs. Participants with the following conditions were excluded, (1) inability to communicate and interact, and (2) dyslexia that prevented completion of the scale. Incomplete and invalid questionnaires were excluded. After independently completing the scale, participants provided feedback on its format, content, clarity, readability, and response options.

Phase II: the scale validation phase

Participants and data collection
From February to May 2024, we performed convenience sampling at the gastrointestinal departments of two tertiary hospitals in Guangzhou and one in Wuhan. The purpose, procedures, potential risks, and benefits of the study were explained to the participants by the nurse investigators. Verbal consent was obtained from those who agreed to participate. Data collection was conducted through an online platform (Wenjuanxing), which could obtain electronic signatures from all participants to document each participant's consent. The inclusion and exclusion criteria were the same as in the pilot study. The sample size of 242 was calculated based on the recommended guidelines, that the subjects to variables ratio should be at least 5 for performing factor analysis,34 while accounting for a 10% loss rate.

Measures and instruments

The colorectal cancer and colonoscopy screening health beliefs scale for first-degree relatives (CCHBS-FDR)
The 37-item CCHBS-FDR with 6 dimensions that measures essential psychosocial variables, namely perceived susceptibility of CRC, perceived severity of CRC, perceived barriers (priority, concerns, and knowledge), perceived benefits derived from the HBM related to colonoscopy screening behavior. Each item is rated on a five-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), with scores ranging from 37 to 185. Higher scores on each dimension indicate higher levels of perception.

The four-item simplified Chinese version of the self-efficacy questionnaire
The four-item simplified Chinese version of the self-efficacy questionnaire was developed to assess the self-efficacy for participating in CRC screening.35 It was translated into simplified Chinese, adapted for colonoscopy testing and indicated satisfactory reliability, with a Cronbach's alpha of 0.77.9 Each item is rated on a five-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). With total score ranging from 4 to 20, a higher score indicated higher self-efficacy for participation in CRC screening.

The cue to action for CRC screening questionnaire
The HBM proposes that health-promoting behaviors require activation by internal or external cues.36, 37, 38 Internal cues involve physiological stimuli (e.g., pain, somatic symptoms), while external cues originate from interpersonal interactions (e.g., advice from healthcare providers or family), media campaigns, or public health communications.36,37,39 The intensity of cues required to prompt action differs among individuals based on perceived susceptibility, severity, benefits, and barriers.37 The cue to action for CRC screening were summarized as family history of CRC, physician's recommendation and health insurance coverage.40 The cue to action for CRC screening questionnaire was a three-item instrument that designed by Bai et al. with these three factors.13 Each item is rated on a five-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The score for cues to action was calculated by averaging the corresponding items (ranging from 1 to 5), with higher score indicating higher cue to action.

The self-designed general information questionnaire
The general information questionnaire developed by the research team was used to gather information about age, sex, marital status, educational level, monthly household income, religion, and CRC family history.

Data analysis

Item analysis
In this step, we analyzed both homogeneity and discrimination. For item homogeneity, we utilized both the (corrected) item–total correlation and the Cronbach's alpha coefficient after each item's removal. Pearson's correlation was employed to calculate item–total correlations. Items with an item–total correlation of less than 0.3, which also resulted in an increase of 0.1 or more in the Cronbach's alpha coefficient upon deletion, were classified as nonhomogeneous. Additionally, we examined factor loadings and communalities to determine whether each item accurately measures the intended latent construct and whether, collectively, they represent the same construct as the other items. Items with communality value less than 0.20 or factor loading less than 0.45 were considered to be not closely related to common factors and should be deleted.
To evaluate discrimination ability, we ranked the total scores of the CCHBS-FDR in descending order, identifying the top 27% as the “high-score group” and the bottom 27% as the “low-score group”.41 For each questionnaire item, we calculated the Critical Ratio value. An item was deemed to have good discriminant validity if its Critical Ratio value was ≥ 3.0 and achieved statistical significance.

Construct validity
Construct validity refers to the extent to which a test actually measures the theoretical structure (concept) and characteristics that it aims to measure. This instrument was developed based on the 4-factor HBM. However, the original 4-factor model demonstrated inadequate fit (χ2/df ​= ​3.254, RMSEA ​= ​0.094, CFI ​= ​0.765, TLI ​= ​0.748, SRMR ​= ​0.089). Brown et al. stated that adjusting dimensions is permissible when the CFI of the original model was < 0.90 and the revised model significantly improves model fit.42 A meta-analysis incorporating 17 studies (n ​= ​2669) demonstrated the independent predictive effect of Health Belief Model variables. This study identified perceived barriers as the strongest predictor of preventive health behaviors and pointed out that the simple four-variable additive model had limited effectiveness in predicting behaviors.43 Additionally, building on our previous research22 and qualitative data (n ​= ​42) revealed that barriers faced by FDRs comprise three components: priority, concerns, and knowledge. Therefore, confirmatory factor analysis (CFA) was used to confirm the 6-factor structural validity, where the original barriers dimension was expanded into three separate factors while maintaining the other core dimensions of the HBM.
Acceptable model fit was determined by meeting the following criteria: the Chi-square/degree of freedom (χ2/df) ​< ​3, root-mean-square error of approximation (RMSEA) ​< ​0.08, standardized root mean square residual (SRMR) ​< ​0.08, Tucker–Lewis index (TLI) ​> ​0.90, comparative fit index (CFI) ​> ​0.90.42,44 If the indices did not suggest adequate model fit, modifications were made to the model based on modification indices (MI), where an MI ​> ​4 indicated that a change would lead to a significant improvement in model fit.45

Convergent validity and discriminative validity
The convergent validity of the model was evaluated through Construct Reliability (CR) and Average Variance Extracted (AVE). A CR value exceeding 0.70 and an AVE value greater than 0.50 were considered indicative of strong convergent validity.46 In addition, AVE values between 0.36 and 0.50 are considered acceptable.46
To assess the discriminant validity of the model, the square root of the AVE for each factor was compared with the correlation coefficients between that factor and all other factors. Good discriminant validity was established if the square root of the AVE for a factor surpassed the correlation coefficients with any other factor.
Known-group comparison was used to assess the scale's ability to differentiate between known different groups of individuals. In alignment with the HBM framework, individuals who have completed colonoscopy screening exhibit higher levels of perceived susceptibility, perceived severity, self-efficacy, and lower levels of perceived barriers (including barriers-priority, barriers-concerns and barriers-knowledge), in contrast to those who have not participated in colonoscopy screening. For subscales with a normal distribution, an independent t test was utilized to compare the mean scores based on colonoscopy screening status. Conversely, for subscales that did not follow a normal distributions, the Mann–Whitney U test was employed to evaluate differences in scores across colonoscopy screening statuses.47

Reliability
The reliability of the CCHBS-FDR was evaluated through internal consistency. Internal consistency was assessed using Cronbach's α, with a value ​> ​0.7 indicating acceptable internal consistency.48

Ethical consideration
This study adheres to the principles of medical ethics, including informed consent, confidentiality, nonmaleficence, beneficence, and fairness. This study was approved by the Ethics Committee of the School of Nursing, Sun Yat-sen University (IRB No. L2024SYSU-HL-054). Data collection was conducted through an online platform (Wenjuanxing), and electronic signatures were collected from all participants to ensure their voluntary participation and protection of their rights and privacy.

Results

Phase I: the scale development phase

Scale construct and item pool
The item pool for the CCHBS-FDR was developed through a systematic and culturally informed process. The RCRCPS, the only existing instrument assessing health beliefs among FDRs of CRC patients, was served as the primary reference for item generation. To ensure comprehensive coverage, a mixed mixed-method systematic review was performed. This review identified several important factors not included in the RCRCPS, such as knowledge about colonoscopy and healthcare professional recommendations, which were subsequently incorporated into our item pool. In addition, to capture the culture-specific items, qualitative interviews with Chinese CRC patients and their relatives were conducted. This process led to the identification and inclusion of culturally specific items, such as family caregiving responsibilities, which are particularly relevant in the Chinese context.
Four major components of the HBM serve as the basis for the dimensional analysis. In the qualitative analysis, barriers were further categorized into three dimensions: priority, concerns, and knowledge. The priority dimension included obstacles related to time, financial costs, and caregiving responsibilities. The concerns dimension addressed various practical barriers and negative emotions experienced by FDRs during the colonoscopy screening process, such as scheduling appointments, bowel preparation, invasive procedures, and others. The knowledge dimension highlighted common misconceptions and gaps in understanding about CRC and colonoscopy, which significantly impacted FDRs’ participation.22 Based on these findings, a six-factor structure was developed, consisting of: perceived severity, perceived susceptibility, perceived benefits, and barriers-priority, concern, and knowledge.
Initially, we obtained 58 items for the item pool. After careful analysis and multiple discussions within the research team, the initial version of the scale was developed, consisting 41 items across six dimensions. The scale used a five-point Likert score (1 ​= ​Strongly Disagree, 5 ​= ​Strongly Agree).

Expert committee review
All 10 members of the expert panel submitted their rating without missing answers. Ten experts’ age ranged from 31 to 57 (41.3 ​± ​8.3) years, and their years of research experience varied from 2 to 34 (16.0 ​± ​10.7) years. The overall authority coefficient and positive coefficients of the experts were 0.96 and 100.0%, respectively, indicating that experts were authoritative and highly interested in the study.
In the first round, experts proposed 37 modification suggestions, mostly overlapped and focused on language or words revision. In addition, based on expert recommendations, the order of items in the perceived severity subscale was adjusted according to the severity of the disease, degree and duration of suffering, as well as the impacts on physiological, psychological, socioeconomic, social, and family support factors. Consequently, 19 items were modified, 1 item were deleted, 1 item were added, and 5 items were merged. The revised scale used in the second round of expert consultation consisted of 38 items.
In the second round of expert consultation, based on expert opinions and discussions among the scale developers, it was recommended that items in the perceived severity subscale should be prefaced with the statement “If I were diagnosed with colorectal cancer …” considering the sensitivity of the cancer-related topic. Moreover, the panel recommends that the time sequence of item 12 and item 13 in the susceptibility subscale should be revised to “within 3 years” and “10 years later”, which would allow FDRs to easily distinguish between short- and long-term risks by quantifying time. As a result, modifications were made accordingly and the modified scale consisted of 37 items across six dimensions. The detailed process of item construction and modification was shown in Appendix A.
The I-CVI was computed as 0.86–1, and the S-CVI/UA was computed as 0.89, the S-CVI/Ave was 0.98. The results showed that the CCHBS-FDR presented acceptable content validity. The expert panel commented that the instrument was culturally and conceptually relevant to measure HBM-related concepts for colonoscopy screening in China.

Pilot testing to verify the face validity of the scale
All the invited FDRs (n ​= ​13) indicated that the instructions, response format, and items of the instruments are clear and comprehensible. Only one-third of FDRs suggested that the dimension order of filling needs to be adjusted. Therefore, based on this feedback, the perceived severity was taken as the first filling dimension after internal discussion among the scale developers. The filling time for the scale ranged from 2.6 to 7.8 (4.7 ​± ​1.7) minutes.

Phase II: the scale validation phase

Sample characteristics
The study was conducted from February 2024 to June 2024. A total of 258 FDRs of patients with CRC were recruited, 90.3% were recruited from the wards. The characteristics of the FDRs are summarized in Table 1. The mean age of the entire sample was 47.4 (standard deviation ​= ​11.1), 53.1% were male, 98.4% were Han ethnic, 86.4% were married, 27.9% received senior high school or associate college education, and 70.2% were employed. About half of the FDRs (56.2%) reported a monthly household income of CNY1-5999. Most of the participants (97.7%) were covered by health insurance. Among the respondents, 78.8% had never received a colonoscopy.

Item analysis
Item 11 (“I currently have a low risk of CRC”) is a reverse-scored item, which contributes to the total score by reassigning the values (1 ​= ​5, 2 ​= ​4, 3 ​= ​3, 4 ​= ​2, 5 ​= ​1). Scores for each subscale were ranked in descending order and are categorized into high and low subgroups based on the upper 27% and lower 27%. The scores for all items were significantly different between the high and low subgroups (P ​< ​0.001), and the CR value was > 3.0. The corrected item–total correlation ranged from −0.019 - 0.863. Item 11 (the corrected item total correlation ​= ​−0.019) fell below the 0.3 criteria, and Cronbach's α of the subscale was raised more than 0.1 upon the deletion of the item. So item 11 was deleted. Except for item 11 (communality value ​= ​0.003), the value of communality for the other items were greater than 0.20 and the factor loading were greater than 0.45, indicating that the homogeneity of the instruments was good. Therefore, the other 36 items were retained for further analysis (Table 2).

Construct validity

Confirmatory factor analysis
The standardized estimates output provided by Amos 25 using maximum likelihood estimation is shown in Fig. 2. The initial six-factor model did not fit well, with χ2/df ​= ​2.833, RMSEA ​= ​0.084, CFI ​= ​0.812, TLI ​= ​0.795, and SRMR ​= ​0.083 (Table 3). These fit indices suggested that the model needed to be modified.
By examining the MI, the largest MI suggested adding a covariance between the errors for c1 and c2 (MI ​= ​87.576), c14 and c15 (MI ​= ​61.249), c29 and c30 (MI ​= ​60.568), c8 and c9 (MI ​= ​55.159). Item 1 (“CRC is a serious disease”) describes the overall severity of CRC, item 2 (“If I were diagnosed with CRC, it would be a serious threat to my health”) is one of the individual consequences of illness, and affecting physiological health is the most common and important serious consequence of the disease. Item 14 is “Colonoscopy can help me know the condition of bowels visually” and item 15 is “Colonoscopy is the best way to detect CRC for me”. Item 14 and 15 express the visual benefits of colonoscopy. The situations described in item 29 and 30 may lead participants to fear that a colonoscopy could cause harm to their body. Item 8 and 9 similarly describe that long-term negative impacts on individuals may indirectly affect families. The covariances between e1 and e2, e14 and e15, e29 and e30, and e8 and e9 were added. After modification, the model still did not fit well with χ2/df ​= ​2.338, RMSEA ​= ​0.072, CFI ​= ​0.863, TLI ​= ​0.850, and SRMR ​= ​0.080.
The MI was examined for the second modified model, and fewer MIs were reported. Most were smaller than the initial model, and the largest remaining MI suggested adding a pathway between c26 and c29 (MI ​= ​36.579), c3 and c4 (MI ​= ​19.522), c20 and c33 (MI ​= ​19.281), and c24 and c37 (MI ​= ​19.027). Item 26 (“The bowel preparation process is complicated and uncomfortable”) and item 29 (“The process of colonoscopy would make me feel pain”) both focus on the physical discomfort associated with the preparation and procedure of a colonoscopy. Item 3 is “If I were diagnosed with CRC, it would make me feel psychologically miserable” and item 4 is “If I were diagnosed with CRC, it would delay my work”, both highlighting the potential burdens associated with a CRC diagnosis. Item 20 is “I don't have time to undergo a colonoscopy” and item 33 is “I don't know about colonoscopy”. The situations described in item 20 reflects the lack of awareness among individuals regarding the importance of CRC screening, which may influence their prioritization of scheduling a colonoscopy. Item 24 (“I feel that undergoing a colonoscopy is an unfortunate event”) and item 37 (“CRC won't happen to me, so I don't need a colonoscopy”) jointly reflect an avoidance tendency toward colonoscopy among participants, with the procedure perceived as unnecessary. Thus, adding covariance between errors for these items is reasonable. After the modification, the model fit noticeably better than the earlier two models, with the fit indices of χ2/df ​= ​2.173, RMSEA ​= ​0.068, CFI ​= ​0.881, TLI ​= ​0.869, and SRMR ​= ​0.079.
The final version of the CCHBS-FDR model including of six factors, but 12 error covariances were added between the error terms for items 1 and 2, items 14 and 15, items 29 and 30, items 8 and 9, items 26 and 29, items 3 and 4, items 20 and 33, items 24 and 37, items 3 and 9, items 18 and 24, items 4 and 27, and items 20 and 21. The final model is shown in Fig. 3.

Convergent validity, discriminant validity and known-groups validity
Regarding convergent validity (Table 4), the AVE for all dimensions exceeded 0.36, while the CR for perceived severity, perceived susceptibility, perceived benefits, barriers-concerns and barriers-knowledge were greater than 0.7, except for barriers-priority (CR ​= ​0.627), indicating relatively ideal convergent validity. As for perceived severity, perceived susceptibility, perceived benefits and barriers-knowledge, the correlation coefficient between that factor and any other factors were less than the square root of the AVE, whereas the correlation coefficients between barriers-concerns and barriers-priority, barriers-knowledge and barriers-concerns were greater than the corresponding AVE square root values. These results suggest that the discriminant validity was not ideal for some dimensions.
The groups were distinguished based on whether they underwent colonoscopy (Table 5). Results indicated that participants who had undergone colonoscopy scored significantly higher in susceptibility and benefits, and significantly lower in priority, concerns, and knowledge than those who had not. No significant differences were observed in severity.

Reliability
Cronbach's α coefficient of the overall scale was 0.863, and Cronbach's α coefficients of perceived severity, perceived susceptibility, perceived benefits, barriers-priority, barriers-concerns and barriers-knowledge were 0.884, 0.689, 0.939, 0.700, 0.899 and 0.855, respectively. It confirmed that the scale had a good internal consistency reliability for the other five dimensions, except for perceived susceptibility.

Discussion
Unlike other at-risk groups for developing CRC, FDRs are typically asymptomatic and therefore require greater motivation to undergo invasive testing.22, 23, 24 Health beliefs related to CRC and colonoscopy screening are crucial for understanding screening behaviors in high-risk populations and serve as important targets for screening interventions. However, the original measurement tool of the RCRCPS, due to several limitations that emerged during its practical implementation, lacks sufficient applicability in real-world settings. Therefore, this study developed and validated the CCHBS-FDR, providing a Chinese culture-specific instrument for assessing health beliefs related to CRC and colonoscopy screening among FDRs of CRC patients, effectively addressing limitations of the original RCRCPS tool.
The original susceptibility subscale in the RCRCPS presented several challenges, particularly in the Chinese context, where multiple items had semantic overlap and temporal expressions were vague, leading to confusion and cognitive burden for respondents. Additionally, the placement of the susceptibility subscale at the beginning of the questionnaire introduced sensitive topics related to CRC risk too early, which could potentially cause psychological discomfort. To address these limitations, we made several key improvements. We consolidated semantically redundant items and adopted culturally appropriate expression to enhance clarity in the Chinese context. To address the issue of ambiguous temporal expressions, we revised the terms based on expert feedback, replacing “some time” with “within the next 3 years” and “in the next few years” with “after 10 years.” These changes help ensure more accurate measurement of individuals' medium- and long-term risk perceptions. Furthermore, the susceptibility subscale was strategically placed after the severity subscale. This structural modification was intended to enhance participant engagement by avoiding the immediate presentation of risk-related items, which could potentially evoke anxiety or resistance among respondents.
In the severity subscale, we likewise consolidated semantically redundant items to enhance clarity (Appendix A). Additionally, career and marital changes consistently received low scores in previous surveys.9 Our qualitative interviews revealed that the original phrasing of career or marital changes may not effectively capture how FDRs in the Chinese context perceive the severity of CRC. In the Chinese context, “career” emphasizes macro-level changes in professional development paths. However, respondents perceived CRC as primarily impacting short-term work status rather than career planning. Instead of associating CRC to changes in career or marital changes, they were more concerned about work disruptions and becoming a burden on their family. To better reflect this cultural perspective, we refined the wording accordingly. Moreover, we incorporated new items based on qualitative interview findings, expanding the original tool to include severity perception items related to threats to physical health, pain of treatment, limitations in social activities, and dietary changes. These modifications enhance the suitability of the CCHBS-FDR for research in the Chinese context.
In terms of perceived benefits, the original items emphasized general benefits, such as early cancer detection and mortality reduction, but did not adequately address the specific factors. Building on insights from our qualitative interviews, the CCHBS-FDR incorporates psychological benefits (e.g., psychological reassurance after screening), preventive benefits (e.g., the role of polyp removal in CRC prevention), and economic benefits (e.g., early detection's role in reducing treatment costs). These factors have been identified in previous studies as key components of perceived benefits.49 These improvements enable a more nuanced evaluation of FDRs' perceived benefits of colonoscopy screening. Additionally, it is essential to recognize that the perceived importance of different aspects of benefits varies across individuals. Researchers can assess the overall benefit score while identifying the top three most prominent benefits to provide critical insights for designing targeted interventions to enhance screening uptake.
The construct of perceived barriers was further categorized into three dimensions: priority, knowledge, and concerns in the CCHBS-FDR. Firstly, in the barriers-priority dimension, the CCHBS-FDR not only retains the time and financial cost-related barriers considered in the original tool but also introduces items related to caregiving responsibilities. Our qualitative research revealed that caregiving and family obligations often hinder FDRs from undergoing colonoscopy screening, consistent with previous studies.24 In our study, perceived barriers are defined as the degree to which various factors are experienced as obstacles to CRC screening. We acknowledge that not all items will apply equally to every participant. Some barriers may be highly relevant to certain individuals, while others may have no impact. While not all FDRs assume caregiving responsibilities, especially if the CRC patient has recovered, the primary recruitment approach for FDRs was through hospital- or community-based CRC patients.50 This recruitment strategy commonly results in participants who have had recent or ongoing involvement in the care of a relative with cancer. Therefore, caregiving demands are a plausible and meaningful barrier for a significant portion of the sample. Given the heterogeneous nature of perceived barriers, researchers can assess the total barrier score, which reflects the overall perceived burden, and identify the top three most significant barriers to inform targeted interventions. Secondly, in the barriers-concerns dimension, we have expanded the scale to include a more detailed consideration of the practical obstacles and emotional concerns FDRs face during the screening process, such as lack of professional advice, cancer taboos, scheduling difficulties, bowel preparation challenges, anesthesia side effects, lack of companionship support, concerns about the invasiveness of the procedure, and screening anxiety. These factors have been shown to be critical barriers to colonoscopy participation, but were not fully captured in the original scale.22,24,51 Thirdly, in the barriers-knowledge dimension, the new items address a broader range of misconceptions and perceived barriers.24 These include a lack of perceived need for screening due to the absence of gastrointestinal symptoms, reliance on routine check-ups, belief in lifestyle prevention, and the perception that CRC will not affect oneself. The CCHBS-FDR integrates existing evidence to offer a comprehensive and nuanced evaluation of the diverse barriers to screening, ensuring greater accuracy and cultural relevance. Finally, 41 items across 6 subscales were generated.
Based on a two-round review by nine experts, items were merged, deleted, and revised, resulting in a 37-item draft instrument. The I-CVI ranged from 0.86 to 1, while the S-CVI/UA and S-CVI/Ave were 0.89 and 0.98, respectively. These values indicate that the items are highly relevant for measuring FDRs' perceived beliefs regarding CRC and colonoscopy screening. The item analysis demonstrated that all items except item 11, have good discrimination and homogeneity. The item 11 “My current risk of developing CRC is low” failed to meet the statistical criteria of homogeneity tests. One possible reason may be that item 11 was to assess perceived low risk, whereas the other items were designed to evaluated high-risk perceptions. This may lead to a cognitive disconnect for respondents, potentially affecting response patterns and internal consistency.
CFA was performed to determine whether the CCHBS-FDR aligns with the proposed six-factor structure. The initial CFA results indicated that fit indices fell below the acceptable thresholds, suggesting the need for model modification. In response, error covariance was added between the error terms of items with the highest MI. After this adjustment, the model fit improved significantly, with the following fit indices: χ2/df ​= ​2.075, RMSEA ​= ​0.065, CFI ​= ​0.892, TLI ​= ​0.880, and SRMR ​= ​0.077. These improved fit indices suggest that the modified model provides a better representation of the data and supports the six-factor structure of the CCHBS-FDR.
The CCHBS-FDR demonstrated robust known-group validity. There was significant difference in susceptibility, benefit, barriers-priority, barriers-concerns, and barriers-knowledge scores between individuals who had undergo colonoscopy and those who had not. However, no significant difference was found in perceived severity scores. The finding aligns with both the RCRCPS validation results and broader literature examining theory-derived relationships between perceived severity and screening behavior.52 Multiple studies have consistently shown that perceived severity of CRC does not effectively discriminate between individuals who participate in CRC screening and those who do not.9,53 This pattern suggests that awareness of CRC's serious nature may be universally high across populations, regardless of their screening behavior.
For reliability, the CCHBS-FDR demonstrated acceptable internal consistency, with a Cronbach's α of 0.689–0.939 for the four subscales. The Cronbach's α of perceived susceptibility was below 0.7. However, this dimension contained three items that reflected different aspects and stages of risk self-assessment: the overall assessment of CRC risk, CRC risk for the short-term and long-term future. These items provided comprehensive information for assessing participants' perception of CRC risk, and therefore it was decided not to remove or modify any items.
In summary, the direct translation of the RCRCPS tool led to inevitably resulted in imprecise wording in the Chinese context and failed to capture culturally specific factors influencing colonoscopy screening among FDRs. To enhance clarity and relevance, we streamlined redundant items based on the RCRCPS tool and refined its wording to align with local perspectives. Additionally, we incorporated key factors uniquely relevant to Chinese FDRs, drawing from qualitative interview data and a system review. These refinements ensure a more precise, culturally attuned assessment of CRC and colonoscopy screening health beliefs, making the CCHBS-FDR a more effective and reliable tool for behavior change interventions. Especially for tailored communication intervention, which was recognized as an effective strategy to promote behavior change by delivering individualized messages based on individual psychosocial characteristics.54,55 In intervention studies, the CCHBS-FDR serves a dual role: it measures changes in health beliefs pre- and post-intervention while also guiding the design of tailored interventions. By systematically assessing individuals’ perceived susceptibility, severity, benefits, and barriers related to CRC and colonoscopy screening, the CCHBS-FDR enables the identification of specific misconceptions, motivational gaps, and barriers that may hinder screening uptake among FDRs. These insights inform the development of personalized intervention strategies, including targeted health messages, tailored educational materials, and barrier-specific support, which to promote screening behavior among FDRs.

Limitations
Several limitations should be acknowledged in this validation study. First, data collection was conducted through an online platform (Wenjuanxing), and despite implementing quality control measures, the possibility of careless responses cannot be completely eliminated. Additionally, the online format precluded the implementation of test-retest reliability assessment. Second, the questionnaire was primarily administered to FDRs of patients in hospital wards, including some whose relatives were newly diagnosed with CRC. These FDRs might not have developed stable health beliefs regarding CRC screening, potentially influencing their response patterns. Future studies should investigate and compare health beliefs among FDRs across different stages of their relatives' disease trajectory, which could provide insights into the dynamic nature of health belief formation and evolution. Furthermore, the effectiveness of this instrument in developing and evaluating screening behavior interventions needs to be rigorously examined. Such validation would establish the tool's practical utility in promoting CRC screening among this high-risk population.

Conclusions
The CCHBS-FDR consists of 36 items across six dimensions, including perceived severity, perceived susceptibility, perceived benefits, barriers-priority, barriers-concerns and barriers-knowledge (Appendix B). It has been demonstrated robust validity as a culturally-specific instrument for assessing the health beliefs among FDRs of people with CRC. It also serves as a valuable instrument for developing and evaluating tailored communication interventions that aimed to promote CRC screening behaviors among FDRs. In future, we will validate the tool with a more diverse sample and explore its effectiveness in developing and evaluating the tailored screening promotion strategies.

CRediT authorship contribution statement
Yingli Yang: Methodology, Formal analysis, Data Curation, Writing - Original draft preparation, Writing - Revised draft preparation. Shuya Lin: Investigation, Formal analysis, Data Curation, Writing - Original draft preparation, Writing - Revised draft preparation. Lei Cai: Resources, Investigation, Data Curation, Writing - Revised draft preparation. Jun Zhong: Resources, Investigation, Data Curation, Writing - Revised draft preparation. Yinxuan Ding: Investigation, Data Curation. Jingyi Wang: Investigation, Data Curation. Baojia Luo: Investigation, Data Curation. Xia Yang: Resources, Investigation, Data Curation. Yang Bai: Supervision, Methodology, Writing - Review and editing. All authors have read and approved the final manuscript.

Ethics statement
The study was approved by the Ethics Committee of the School of Nursing, Sun Yat-sen University (IRB No. L2024SYSU-HL-054) and was conducted in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All participants provided both oral consent and an electronic signature of the informed consent form.

Data availability statement
The data that support the findings of this study are available from the corresponding author, BY, upon reasonable request.

Declaration of generative AI in scientific writing
No AI tools/services were used during the preparation of this work.

Funding
This work was funded by National Natural Science Foundation of China (Grant No. 72204279) and Young Science and Technology Talent Support Program of Guangdong Precision Medicine Application Association (Grant No. YSTTGDPMAA202502). The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication.

Declaration of competing interest
The authors declare no conflict of interest. The corresponding author, Dr. Yang Bai, is an editorial board member of Asia–Pacific Journal of Oncology Nursing. The article was subject to the journal's standard procedures, with peer review handled independently of Dr. Bai and their research groups.